Medical affairs outsourcing refers to outsourcing non-core medical capabilities and services related to medical affairs functions to contract service providers. This includes medical information, medical communications, medical monitoring, medical science liaisons (MSLs), medical education, and regulatory affairs among others. The Medical Affairs Outsourcing Market has witnessed significant growth in recent years owing to increased focus of pharmaceutical companies on core operations. Medical affairs outsourcing enables pharmaceutical companies to focus on drug discovery and commercial aspects while outsourcing non-core medical functions.
The Global Medical Affairs Outsourcing Market is estimated to be valued at USD 2.60 Bn in 2025 and is expected to exhibit a CAGR of 12.5% over the forecast period of 2025 to 2032.
Key Takeaways Key Players: Key players operating in the Medical Affairs Outsourcing Market include IQVIA Holdings Inc., Ashfield (part of UDG Healthcare plc), Syneos Health, and Parexel International. These players have established global presence and offer end-to-end medical affairs outsourcing services. Key Opportunities: Growing pharmaceutical industry, increasing drug development activities, and focus on core competencies offer significant growth opportunities for players in the Medical Affairs Outsourcing Market Demand. Outsourcing of new therapy areas and complex protocol designs present remunerative opportunities. Global Expansion: Key players are expanding globally through acquisitions and partnerships to strengthen their service portfolio and geographic footprint. Players are also focusing on emerging markets in Asia Pacific and Latin America which are expected to exhibit high growth. Market Drivers and Restraints Drivers: - Increased focus of pharmaceutical companies on core operations is a major driver as it allows them to outsource non-core medical functions. - Growing pharmaceutical R&D expenditure and clinical trials also drives demand for medical affairs outsourcing services. Restraints: - Data privacy and security concerns limit scope of outsourcing for critical functions. Regulatory policies also impact outsourcing of certain regions and domains. - Loss of control and lack of integration with in-house functions are challenges faced due to outsourcing of medical affairs capabilities. Segment Analysis The Medical Affairs Outsourcing Market is dominated by the clinical development and publications sub-segment. This sub-segment accounts for over 35% of the market share as biopharma companies extensively outsource clinical activities including data management, medical writing, and clinical trial applications to CROs in order to focus on core competencies. The demand is high as medical affairs outsourcing helps accelerate clinical research and expedites new product launches. Global Analysis North America holds the major share in the Medical Affairs Outsourcing Market and is expected to continue its dominance during the forecast period. This is attributed to increasing R&D expenditure by biopharmaceutical companies and growing presence of CROs in the region. Asia-Pacific is projected to witness the highest growth rate owing to rising healthcare expenditure, availability of large patient population for clinical trials, and less stringent regulatory policies. China, India, and Japan are emerging as lucrative outsourcing destinations and are expected to offer new opportunities for market players for low-cost services and operations.
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The medical device regulatory affairs outsourcing market is expected to gain market growth in the forecast period of 2021 to 2028.
The strategic initiative for geographical expansions is anticipated to drive the growth of the medical device regulatory affairs outsourcing market.Request Sample Copy of Report @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-medical-device-regulatory-affairs-outsourcing-marketOutsourcing is an important part of every pharmaceutical and biotechnology companies’ value chain during research and development (R).
The regulatory affairs outsourcing services entail medical writing and publication of regulatory documentation by professional medical authors, quality control (QC) auditors and publishers who contribute to high-quality clinical research projects.
The demand for regulatory services outsourcing has been fueled by a substantial increase in clinical studies conducted in emerging economies, providing a healthy platform for this industry's growth.The increasing number of patent expirations acts as driver for its growth in the medical device regulatory affairs outsourcing market.
The fluctuation in the prices of various medical devices regulatory affairs services acts as restraint for its growth in the medical device regulatory affairs outsourcing market.
The pandemic outbreak of COVID-19 acts as challenge for the growth of the medical device regulatory affairs outsourcing market.The medical device regulatory affairs outsourcing market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market.
According to the report, the global medical device & IVD regulatory affairs outsourcing market was valued at US$ 1.03 Bn in 2019.
It is projected to expand at a CAGR of ~11% from 2020 to 2030.
Regulatory affairs (RA) play a critical role in the medical device & IVD industry, as it is concerned about the lifecycle of the healthcare product, provides strategic, tactical, and operational direction and support to work within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.Request Brochure – https://www.transparencymarketresearch.com/sample/sample.php?flag=B_id=79264In terms of service, the global medical device & IVD regulatory affairs outsourcing market has been classified into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others.
Increase in regulatory requirements and expansion of the medical device industry boost the global medical device & IVD regulatory affairs outsourcing market.North America dominated the global medical device & IVD regulatory affairs outsourcing market in 2019, and the trend is anticipated to continue during the forecast period.
Preference for business expansion in countries such as India and China by companies due to favorable business environment is likely to boost the regulatory affairs outsourcing market in these countries.Expansion of Medical Device Industry and Increase in Regulatory Requirements to Drive Global MarketThe medical device industry is expanding at a rapid pace, driven by innovative technology, and improvement in diagnosis, treatment, and delivery.
Low cost of cloud-based technology and rapid implementation are key factors likely to augment the segment.Buy Medical Device & IVD Regulatory Affairs Outsourcing Market Report –https://www.transparencymarketresearch.com/checkout.php?rep_id=79264=S Competition LandscapeFreyr, Covance, ICON plc, and Emergo are the four major companies operating in the global medical device & IVD regulatory affairs outsourcing market.
